510(k) K964121 ยท JCT Prosthesis, Tracheal, Expandable
WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS
| Applicant | Boston Scientific Scimed, Inc., Plymouth MN, US |
| Decision | Substantially Equivalent - Subject to Tracking Reg., Dec 4, 1996 |
| Received | Oct 15, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964121
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 15, 2011 | Boston Scientific Corporation Boston Scientific, WALLSTENT" Endoprosthesis & WALLSTENT" RP Endoprosthesis, Self Expanding Stent, Stent Auto-expanisvel, Made in Ireland, Ballybrit Business Park, Galway, IRELAND, STERILE, EO.
Ind Terminated |
JCT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.